Trials / Active Not Recruiting
Active Not RecruitingNCT06669754
Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- Sponsor
- Pharvaris Netherlands B.V. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.
Detailed description
The study consists of a Screening Period during which eligibility is confirmed, a Treatment Period of 24 weeks, and a Follow-up Period of maximum 4 weeks or subjects may roll over into the open-label study PHA022121-C307 (CHAPTER-4). During the Treatment period participants will receive blinded study drug (deucrictibant or placebo randomized in a 2:1 ratio). Participants will undergo regular efficacy and safety assessments, complete an electronic diary daily, and also complete questionnaires at predefined timepoints during the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Deucrictibant | Deucrictibant 40mg extended-release tablet for once daily oral use |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2024-11-01
- Last updated
- 2026-02-13
Locations
56 sites across 24 countries: United States, Argentina, Brazil, Bulgaria, Canada, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, New Zealand, Poland, Puerto Rico, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06669754. Inclusion in this directory is not an endorsement.